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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________________
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`New World Medical, Inc.,
`Petitioner
`
`v.
`
`MicroSurgical Tech., Inc.,
`Patent Owner
`
`_______________________
`
`Case No. IPR2020-01573
`
`U.S. Patent Nos. 9,107,729
`________________________
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`PETITIONER’S MOTION TO STRIKE THE
`AFFIDAVIT OF MANUEL QUINTANA (EXHIBIT 2020)
`__________________________________________________________________
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`TABLE OF CONTENTS
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`I.
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`INTRODUCTION ............................................................................................... 1
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`II.
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`BACKGROUND ............................................................................................. 1
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`III. LEGAL STANDARD ..................................................................................... 4
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`IV. THE BOARD SHOULD STRIKE THE AFFIDAVIT
`(EX.2020) ................................................................................................................... 4
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`i
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`Cases
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`TABLE OF AUTHORITIES
`
`HTC Corp. v. NFC Tech., LLC, IPR2014-01198, Paper 41 (PTAB
`Nov. 6, 2015) ................................................................................................. 4, 5, 7
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`John’s Lone Star Distrib., Inc. v. Thermolife Int’l, Inc., IPR2014-
`01201, Paper 31 (PTAB May 13, 2015) .............................................................5, 6
`
`Square Inc. v. REM Holdings 3, LLC, IPR2014-00312, Paper No. 37
`(PTAB Dec. 9, 2014) .............................................................................................. 6
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`Other Authorities
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`PTAB Consolidated Trial Practice Guide (Nov. 2019) .........................................4, 7
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`Regulations
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`37 C.F.R. §42.12(a)(1) ...........................................................................................4, 6
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`37 C.F.R. §42.12(b)(2) ...........................................................................................4, 6
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`37 C.F.R. §42.51(b)(1)(ii) ............................................................................. 1, 2, 4, 5
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`ii
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`PETITIONER’S UPDATED EXHIBIT LIST
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`Description
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`U.S. Patent 9,107,729 (“the ‘729 patent”)
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`U.S. Patent 9,107,729 File History (‘729 patent file history”)
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`Exhibit
`No.
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`1001
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`1002
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`1003
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`Declaration of Dr. Peter Netland (“Decl.”)
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`1004
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`1005
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`1006
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`1007
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`1008
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`1009
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`1010
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`1011
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`Manuel Quintana, Gonioscopic Trabeculotomy. First Results, in 43
`SECOND EUROPEAN GLAUCOMA SYMPOSIUM, DOCUMENTA
`OPHTHALMOLOGICA PROCEEDINGS SERIES 265 (E.L. Greve, W.
`Leydhecker, & C. Raitta ed., 1985) (“Quintana”)
`
`M. Johnstone et al., “Microsurgery of SC and the Human Aqueous
`Outflow System,” Am. J. Ophthalmology 76(6):906-917 (1973)
`(“Johnstone”)
`
`U.S. Patent 4,900,300 to Lee (“Lee”)
`
`Philipp C. Jacobi et al., “Technique of goniocurettage: a potential
`treatment for advance chronic open angle glaucoma,” 81 BRITISH J.
`OPHTHALMOLOGY 302-307 (1997) (“Jacobi”)
`
`Richard S. Snell et al., Clinical Anatomy of the Eye, Malden,
`Massachusetts: Blackwell Science, Inc. (2nd ed., 1998) (“Snell”)
`
`Am. Acad. Of Ophthalmology, Section 8 External Disease and
`Cornea, in BASIC AND CLINICAL SCIENCE COURSE 2001-2002
`(2001) (“AAO Cornea”)
`
`Michael John Hogan, History of the Human Eye: An Atlas and
`Textbook. Philadelphia, Pennsylvania: W. B. Saunders Company
`(1971) (“Hogan”)
`
`M. Bruce Shields, Textbook of Glaucoma, Fourth Edition.
`Baltimore, Maryland: Williams & Wilkins (1998) (“Shields”)
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`iii
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`Exhibit
`No.
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`1012
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`1013
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`1014
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`1015
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`1016
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`1017
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`1018
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`1019
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`1020
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`Description
`
`Am. Acad. Of Ophthalmology, Section 10 Glaucoma, in BASIC
`AND CLINICAL SCIENCE COURSE 2000-2001 (2000) (“AAO
`Glaucoma”)
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`Phillip C. Jacobi et al., “Perspectives in trabecular surgery,” Eye
`2000;14(Pt 3B)(3b):519-530 (2000) (“Jacobi 2000”)
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`F. Skjaerpe, “Selective Trabeculectomy. A Report of a New
`Surgical Method for Open Angle Glaucoma,” Acta
`Ophthalmologica 61:714-727 (1983) (“Skjaerpe 1983”)
`
`U.S. Patent Application Publication 2002/0111608 to Baerveldt
`(“Baerveldt”)
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`U.S. Patent 4,501,274 to Skjaerpe (“Skjaerpe ‘274”)
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`Microsurgical Technology, Inc. v. New World Medical, Inc., No.
`1:20-cv-00754, Doc. 1 (D. Del. June 4, 2020) (“Complaint”)
`
`E. Ferrari et al., “Ab-interno trabeculo-canalectomy: surgical
`approach and histological examination,” European J.
`Ophthalmology 12(5):401-05 (2002) (“Ferrari”)
`
`U.S. Patent App. 13/159,356 File History (‘356 application file
`history”)
`
`T. Shute, “A Novel Technique for Ab Interno Trabeculectomy:
`Description of Procedure and Preliminary Results,” Am. Glaucoma
`Society 29th Annual Meeting Poster Abstracts 34-35 (2019)
`(available at: https://ags.planion.com/Web.User/
`AbstractDet?ACCOUNT=AGS&CONF=AM19&ABSID=12309)
`(“Shute”)
`
`1021
`
`Arsham Sheybani, Bent Ab-interno Needle Goniectomy (BANG),
`YouTube (Aug. 24, 2017), https://youtu.be/b5QxWts-Pxs (“BANG
`Video”)
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`iv
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`Exhibit
`No.
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`1022
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`1023
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`1024
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`1025
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`1026
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`1027
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`1028
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`1029
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`Description
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`PROTECTIVE ORDER MATERIAL ATTORNEYS EYES ONLY
`– License Agreement
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`Reserved
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`Proposed Protective Order
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`Redlined Proposed Protective Order
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`Transcript of Telephonic Hearing Held on Thursday, July 15, 2021
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`Transcript of Telephonic Hearing Held on Friday, August 13, 2021
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`Email Correspondence Regarding Dr. Quintana’s Deposition
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`Joint Correspondence to Dr. Quintana Regarding Deposition
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`v
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`I.
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`INTRODUCTION
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`In accordance with the Board’s August 13, 2021 authorization, Petitioner
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`New World Medical, Inc. (“NWM”) respectfully submits this motion requesting
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`that the Board strike the “Sworn Affidavit of Manuel Quintana, M.D.” (Ex.2020)
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`(“the Affidavit”) from the record in this proceeding. The Board’s rules require a
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`party proffering a witness’s testimony to make that witness available for cross-
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`examination as routine discovery. 37 C.F.R. §42.51(b)(1)(ii). Despite submitting
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`the Affidavit in support of its Patent Owner Response in this proceeding, Patent
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`Owner has not made Dr. Quintana available for cross-examination with Dr.
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`Quintana not even responding to requests to schedule a deposition. Accordingly,
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`the Board should strike the Affidavit and expunge it from the record.
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`II. BACKGROUND
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`On June 8, 2021, Patent Owner filed its Response (Paper 29) and supporting
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`materials, including the Affidavit (Ex.2020). The Affidavit was prepared for this
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`proceeding and apparently executed by a Manuel Quintana, M.D. on May 17, 2021
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`in Barcelona, Spain. Ex.2020, 3. The affiant purports to be the same Manuel
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`Quintana who authored a prior art reference relied upon by NWM—Exhibit 1004
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`(“the Quintana Reference”). The Affidavit contradicts and attempts to rewrite the
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`Quintana Reference some 35 years after the reference was published. Testing this
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`contradictory affidavit via cross-examination is imperative.
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`1
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`On June 29, 2021, NWM contacted Patent Owner to request the deposition
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`of Dr. Quintana as routine discovery under 37 C.F.R. §42.51(b)(1)(ii). Ex.1028, 2-
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`3. Patent Owner responded on June 30, 2021, indicating Dr. Quintana would not be
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`made available for deposition in the United States. Id., 2. After several additional
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`email exchanges and a meet and confer between the parties, NWM requested a call
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`with the Board to seek guidance regarding Dr. Quintana’s deposition. On July 15,
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`2021, the Board held a conference call regarding Dr. Quintana’s deposition where
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`Patent Owner stated that it did not represent Dr. Quintana. See Ex.1026, 3 (8:23-
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`25). After hearing the parties’ positions, the Board ordered the parties to work
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`together to secure Dr. Quintana’s deposition in Spain. Id., 5 (17:8-24).
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`The parties prepared a letter to Dr. Quintana requesting that he make himself
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`available for deposition in Spain. Patent Owner’s counsel sent the letter via email
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`and expedited international delivery to Dr. Quintana on July 19, 2021. Ex.1029.
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`Although purportedly a “joint” correspondence, Patent Owner’s counsel did not
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`disclose Dr. Quintana’s email to NWM and redacted Dr. Quintana’s contact
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`information in the letter. Id. On August 10, 2021, after receiving no response from
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`Dr. Quintana and given the approaching due dates for NWM’s reply briefs in the
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`related IPR proceedings, NWM requested another conference call with the Board.
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`On August 13, 2021, the Board held a second teleconference. Ex.1027.
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`NWM explained that Dr. Quintana had still not responded to the deposition request
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`2
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`and asked for authorization to file a motion to strike the affidavit. Id., 2-3 (5:17-
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`7:13). Patent Owner reiterated that it does not control or represent Dr. Quintana but
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`that it did not object to NWM pursuing the motion. Id., 3 (7:16-8-12). The Board
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`also questioned how Dr. Quintana’s Affidavit was procured in the first place.
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`Patent Owner explained that it obtained contact information for Dr. Quintana
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`through individuals at the University of Barcelona, which they used to set up a
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`teleconference with Dr. Quintana. Patent Owner has apparently not spoken to Dr.
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`Quintana since. Id., 3-4 (8:17-10:19). The Board further questioned how Patent
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`Owner knew it was dealing with the actual Dr. Quintana, to which Patent Owner
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`responded that it assumed it is the correct Dr. Quintana due to the affiant’s
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`knowledge of the Quintana Reference. Id., 4 (10:20-12:7). The Board also noted
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`that, despite the affidavit being notarized, the “notarization is just about as good as
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`anything else in the exhibit.” Id. The Board subsequently authorized NWM to file
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`the present motion to strike the Affidavit in this proceeding and the related IPRs.
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`Id., 4-5 (12:14-14:3).1
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`1 The Board also suggested that the parties continue to make efforts to secure Dr.
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`Quintana’s deposition. Id., 5 (14:10-15:1). Patent Owner is in sole possession of
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`Dr. Quintana’s contact information but, to NWM’s knowledge, Patent Owner has
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`3
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`III. LEGAL STANDARD
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`“Discovery is a tool to develop a full record and to aid the Board in
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`assessing the credibility of witnesses.” PTAB Consolidated Trial Practice Guide
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`(Nov. 2019) (“TPG”) at 22. “Routine discovery places the parties on a level
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`playing field and streamlines the proceeding.” Id., 23. Under 37 C.F.R.
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`§42.51(b)(1)(ii), cross-examination of affidavit testimony prepared for the
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`proceeding is routine discovery. As such, “if a party proffers a witness’s
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`testimony, that party must make that witness available for cross-examination by
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`the other party.” HTC Corp. v. NFC Tech., LLC, IPR2014-01198, Paper 41 at 3
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`(PTAB Nov. 6, 2015) (emphasis added). The requirement for cross-examination
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`“applies to witnesses employed by a party as well as experts and non-party
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`witnesses.” TPG at 23. When a party proffering a witness’s testimony fails to make
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`the witness available for cross-examination, the Board may strike the witness’s
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`testimony. HTC, IPR2014-01198, Paper 41 at 5; 37 C.F.R. §§42.12(a)(1), (b)(2).
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`IV. THE BOARD SHOULD STRIKE THE AFFIDAVIT (EX.2020)
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`The Affidavit should be stricken and expunged from the record because Dr.
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`Quintana has not been made available for cross-examination. The Affidavit (Ex.
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`made no additional attempts to contact Dr. Quintana beyond the parties’ July 19,
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`2021 communication.
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`4
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`2020) was undisputedly prepared for the related IPR proceedings and submitted by
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`Patent Owner in support of its Patent Owner Responses. Under the Board’s rules
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`governing routine discovery, Patent Owner must make Dr. Quintana available for
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`cross-examination by NWM. 37 C.F.R. §42.51(b)(1)(ii). Patent Owner has not
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`done so. Accordingly, the Affidavit should be stricken from the record.
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`The Board has previously stricken witness testimony under similar
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`circumstances. In HTC, the Board struck the declaration of a witness who refused
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`to appear for deposition “for personal reasons.” IPR2014-01198, Paper 41 at 3. The
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`Board rejected the Patent Owner’s arguments that it did not employ or have control
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`over the witness, finding that “Patent Owner is responsible for the availability of
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`its chosen declarants, regardless whether or not they are employed by Patent
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`Owner.” Id., 4. The Board held that “responsibility for its declarant’s refusal to
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`participate in the deposition ultimately must rest with . . . the party proffering the
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`witness,” and therefore granted the motion to strike. Id., 5. Similarly, in John’s
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`Lone Star Distrib., Inc. v. Thermolife Int’l, Inc., IPR2014-01201, Paper 31 at 3
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`(PTAB May 13, 2015), the Board granted a motion to strike the declaration of a
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`witness who was not made available for cross examination. According to the
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`Board, “[b]y refusing to make [the witness] available for cross-examination,
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`Petitioner has failed to comply with an applicable rule in this proceeding, entirely
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`to Patent Owner’s detriment. Thus, an appropriate action is to expunge [the
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`5
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`declaration].” Id. (citing 37 C.F.R. § 42.12(a)(1), (b)(2)); see also Square Inc. v.
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`REM Holdings 3, LLC, IPR2014-00312, Paper No. 37 at 2-3 (PTAB Dec. 9, 2014)
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`(witness must be made available for cross-examination or be withdrawn). As in
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`HTC and John’s Lone Star, here Patent Owner is solely responsible for Dr.
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`Quintana and the Affidavit, and the failure to make Dr. Quintana available for
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`deposition calls for the testimony to be struck from the record.
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`Moreover, the failure to make Dr. Quintana available for deposition is
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`extremely prejudicial to NWM. At a basic level, NWM should have an opportunity
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`to cross-examine Dr. Quintana regarding the Affidavit. The Affidavit, written for
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`this proceeding some 35 years after publication of the Quintana Reference,
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`contradicts and attempts to rewrite portions of the reference. For example, the
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`Affidavit asserts that understandable terms in the Quintana Reference such as
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`“sectioned” and “stripped” now mean “an incision or opening”—despite the fact
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`that the Quintana Reference uses “incise” and “opening” elsewhere, indicating the
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`author knew how to use those terms and chose not to. Even Patent Owner’s
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`counsel admitted Dr. Quintana’s Affidavit “seeks to clarify what his article meant
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`to report.” Ex.1026, 3 (8:20-22) (emphasis added). Similarly, despite writing the
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`Quintana Reference in English, English is apparently not Dr. Quintana’s primary
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`language (Ex.1026, 3 (8:3-5)) and the parties’ joint letter required translation.
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`NWM should have the opportunity to question Dr. Quintana regarding his
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`6
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`Affidavit on this front. And, as the Board noted, there is nothing to guarantee the
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`author of the Affidavit is the same person that authored the Quintana Reference.
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`Ex.1027, 4 (10:20-12:7). NWM’s inability to depose Dr. Quintana is prejudicial
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`and shows why, without cross-examination, the Affidavit should be stricken.
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`Finally, the fact Dr. Quintana is a non-party and that Patent Owner does not
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`control Dr. Quintana is irrelevant. The Board’s rules make clear that the cross
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`examination requirement “applies to witnesses employed by a party as well as
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`experts and non-party witnesses.” TPG at 23; see also HTC, IPR2014-01198,
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`Paper 41 at 4. Patent Owner should have known these rules when it submitted the
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`Affidavit and confirmed that, despite being a third party, Dr. Quintana would
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`submit to a deposition regarding his affidavit testimony. Moreover, the Board’s
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`clear rules on routine discovery should be followed to avoid prejudice to NWM.
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`Accordingly, the Board should respectfully grant Petitioner’s Motion to
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`Strike and expunge the Quintana Affidavit (Ex. 2020) from the record.2
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`2 The Affidavit is also cited in Patent Owner’s Responses and expert declarations
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`(Ex.2019) in each of the related IPRs. While NWM believes striking portions of
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`Patent Owner’s filings that rely on the Affidavit is appropriate, the Board should at
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`minimum give no weight to any reliance on the Affidavit in Patent Owner’s papers
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`and other filings. See HTC, IPR2014-01198 at 5.
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`7
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`Dated: August 20, 2021
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`Respectfully submitted,
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`/s/ Todd R. Tucker
`Todd R. Tucker (Reg. No. 40,850)
`ttucker@calfee.com
`Kyle Deighan (Reg. No. 75,525)
`kdeighan@calfee.com
`CALFEE, HALTER & GRISWOLD LLP
`The Calfee Building
`1405 East Sixth Street
`Cleveland, Ohio 44114
`P: 216-622-8200
`F: 216-241-0816
`
`for Petitioner New World.
`Attorneys
`Medical, Inc.
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`8
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that the foregoing PETITIONER’S MOTION
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`TO STRIKE THE SWORN AFFIDAVIT OF MANUEL QUINTANA, M.D.
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`(EXHIBIT 2020) and EXHIBIT NOS. 1027-1029 were served as of the below
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`date by e-mail on the following individuals and email addresses of record:
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`Lawrence M. Sung (lsung@wiley.law)
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`Mary Sylvia (msylvia@wiley.law)
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`Teresa M. Summers (tsummers@wiley.law)
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`Dated: August 20, 2021
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`/s/ John L. Reulbach III
`John L. Reulbach III
`Attorney for Petitioner
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`1
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